- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05432102
Patient Experience and Technical Success of Community Sleep Studies (PETSOCSS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is a study underway to develop a non-contact detector of breathing (SafeScan) as a new method of diagnosing obstructive sleep apnoea (OSA). There are a number of different methods already available to achieve this end but one proposed advantage of the new SafeScan device is that it will not affect sleep quality and because there are no measuring devices attached to the patient it is less likely that the signal will be lost in the night due to the normal movements of sleep. However there are no data available that quantify these factors as an issue for the current techniques and devices.
The proving study for SafeScan is a comparison of the ability of the device to measure sleep apnoea compared to full in-hospital polysomnography (PSG) and one outcome will be the proportion of studies that have lost data. However the future use of the SafeScan device will be in the community. The common diagnostics used by patients in their own homes are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. We propose a study to examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between. In addition there will be an analysis of the results to explore whether there are features of the patients such as age and obesity that make technical success or failure of the studies more likely.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Katharine Woodall
- Phone Number: +44 1223 639636
- Email: katharine.woodall@nhs.net
Study Contact Backup
- Name: Joanna Raynor
- Phone Number: +44 1223 639699
- Email: joanna.raynor1@nhs.net
Study Locations
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Cambridge, United Kingdom
- Recruiting
- Royal Papworth Hospital NHS Foundation Trust
-
Contact:
- Earl Palas
- Phone Number: +44 1223 638410
- Email: earl.palas@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study
Exclusion Criteria:
Patients unable to complete questionnaires due to language or other barriers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants having respiratory polygraphy
This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.
|
Diagnostic intervention to diagnose OSA.
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Participants having pulse oximetry
This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.
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Diagnostic intervention to diagnose OSA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfactory sleep studies
Time Frame: 3 months
|
The proportion of home studies to diagnose sleep apnoea that are satisfactory without disruption to the patient's sleep or loss of signals to an extent that make the results unreliable.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of sleep disruption
Time Frame: 3 months
|
What proportion of patients report sleep disruption due to: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?
|
3 months
|
Extent of signal failure
Time Frame: 3 months
|
What proportion of studies failed due to loss of signal from: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P02530
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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